TARGET M0035466200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540676276), received between Mar 16, 2021 and Sep 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE WHEN THE SUBJECT COIL WAS BEING DELIVERED INTO THE ANEURYSM, THE PHYSICIAN NEEDED TO ADJUST THE DELIVERY CONFIGURATION. UPON ADJUSTMENT, THE COIL PREMATURELY DETACHED HALF IN THE ANEURYSM AND HALF IN THE MCA VESSEL. THE PHYSICIAN USED TWO RETRIEVERS TO ATTEMPT TO RETRIEVE THE COIL BUT WAS UNSUCCESSFUL AND THE RETRIEVER FELL INTO THE ANEURYSM. THE PHYSICIAN ABANDONED THE PROCEDURE AFTER A 60 MINUTE DELAY. THE PATIENT WAS TRANSFERRED TO NEUROSURGERY FOR A FOR CLIPPING AND COIL REMOVAL. THE PATIENT HAD VASOSPASM DURING THE INTERVENTION AND SUFFERED MCA STROKE AFTERWARDS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; Stroke/CVA; Vasoconstriction

  MAUDE report 22940800 ↗
• MalfunctionMar 16, 2021Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR LEFT ICA (INTERNAL CAROTID ARTERY) ANEURYSM CASE, PHYSICIAN USED MICROCATHETER TO INSERT SUBJECT COIL. WHEN INSERTING THE SUBJECT COIL, ITS WAS NOTED THAT THE PROXIMAL PORTION HAD STRETCHED DURING THE FRAMING IN ANEURYSM AND THAT THE CORE WIRE HAD FLOWED TO THE DISTAL PART OF THE VESSEL. THE PHYSICIAN TRIED TO WITHDRAW SUBJECT COIL, BUT THE PROXIMAL PORTION HAD FRACTURED AND WAS LEFT BEHIND UPON REMOVAL. A SNARE DEVICE WAS USED TO RETRIEVE THE FRACTURED FRAGMENT OF SUBJECT COIL AND ANOTHER COIL WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WERE NOTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499504 ↗